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Key Process Operations Manager
2 weeks ago
We are seeking a highly skilled Process Support Specialist to join our team in Carlow, Ireland. This is an exciting opportunity to be involved with critical investment projects both on-site and remotely.
Job Description:
Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT. Be a document system expert; this will include document review, approval, and document system workflow expedition. Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls.
Required Skills and Qualifications:
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
- SAP knowledge and experience required.
- Proficiency in Microsoft Office and job-related computer applications required.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Report, standards, policy writing skills required.
- Equipment and process validation
- Sterile filling processes and equipment
- Lean Six Sigma Methodology experience desired.
Benefits:
- Opportunity to be involved with critical investment projects
- Work in a dynamic environment with like-minded professionals
